Description

5-(4-Hydroxyphenyl)-5-Phenyl-D5-Hydantoin-15N2 is a stable isotope-labeled analog of the pharmaceutical intermediate phenytoin, specifically deuterated and nitrogen-15 enriched. This compound is essential for use as an internal standard in quantitative mass spectrometry, providing unmatched accuracy and reliability for pharmacokinetic and metabolic studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in bioanalytical method development and drug metabolism research.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of phenytoin and its metabolites in complex biological matrices like plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracing and measurement of drug absorption, distribution, metabolism, and excretion (ADME) studies.
• Bioanalytical Method Development and Validation: Serves as a reference standard to establish selective, sensitive, and robust analytical assays compliant with FDA and ICH guidelines.
• Therapeutic Drug Monitoring (TDM): Used in assays to monitor phenytoin levels in patient samples for dose optimization and toxicity prevention.
• Pharmaceutical Impurity Profiling: Aids in the identification and quantification of process-related impurities or degradants in active pharmaceutical ingredient (API) batches.
• Isotope Dilution Mass Spectrometry (IDMS): Employed in high-precision analytical techniques for definitive measurement in clinical and forensic toxicology.

Basic Information

Product Name	5-(4-Hydroxyphenyl)-5-Phenyl-D5-Hydantoin-15N2
CAS No.	369656-71-3
Molecular Formula	C15H8D5N215O2
Molecular Weight	~263.30 g/mol
Synonyms	Phenytoin-d5-15N2; 5,5-Diphenylhydantoin-d5-15N2; 5-(4-Hydroxyphenyl)-5-phenyl-2,4-imidazolidinedione-d5-15N2; Dilantin-d5-15N2 (labeled analog); DPH-d5-15N2; [2,4-13C2; D5; 15N2]-5,5-Diphenylhydantoin; Stable Isotope Labeled Phenytoin; 5-(p-Hydroxyphenyl)-5-phenylhydantoin-d5-15N2
EINECS	Contact for details

Quality Control

Our stable isotope-labeled compounds are manufactured under strict quality control protocols to ensure the highest isotopic purity and chemical integrity. Each batch is characterized using advanced techniques including NMR, HPLC, and high-resolution mass spectrometry. Certificates of Analysis (COA) are provided, detailing isotopic enrichment (atom % D and 15N), chemical purity, and chromatographic data to support your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D)	≥98 atom % D
Isotopic Purity (15N)	≥98 atom % 15N
Chemical Purity	≥95%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.